Opportunity W81XWH-10-PCRP-LCTA

The summary for the Opportunity W81XWH-10-PCRP-LCTA grant is detailed below.
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Opportunity W81XWH-10-PCRP-LCTA: The PCRP Laboratory Clinical Transition Award mechanism was introduced in FY07. Since then, 36 applications have been received, and 6 have been recommended for funding. The Laboratory Clinical Transition Award supports goal- and product-driven preclinical studies of promising lead agents that have the potential to revolutionize prostate cancer clinical care. This award is intended to fund PIs who lack support to conduct the preclinical studies needed to advance lead agents to human testing. The goal of this award is the generation of pharmacology and toxicology data for inclusion in a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application prior to current Good Manufacturing Practice (cGMP) production of the lead agent(s). Agents supported by this award mechanism are expected to have high potential for commercial licensing for continued development and clinical use. Applicants are expected to have a validated target, and to have identified either one lead agent or a limited number of lead agents for optimization before applying for this award. In addition, the PI should present data establishing the mechanism of action of the lead agent(s) on the target. Lead agents are defined as novel biological, molecular, or chemical therapeutics or imaging agents, that have potential clinical application to prostate cancer. Examples of lead agents include, but are not limited to: novel chemotherapeutics, antibodies, nanoparticles, and imaging contrast agents. Proposals must include preliminary data relevant to the lead agent(s) under development. Preliminary data must document target availability and distribution in relevant human tissues, and must provide substantive information from model systems that supports the potential efficacy of the lead agent(s) in humans. The National Cancer Institute (NCI) has constructed developmental pathways for translational research that may be useful for designing translational research studies for support under this mechanism. These pathways are comprehensive and span the entire translational research continuum from discovery of a target to clinical trials (http://www.cancer.gov/images/trwg/Developmental-Pathway-Agent-Drug_Biologics.pdf). Please note that the focus of this award is to support the development of the lead agent(s) up to but not including cGMP production of the agent. Studies proposed under this award may include, but are not limited to: - Comparative activity/efficacy testing to optimize a lead agent and/or define a single lead agent from a limited library of candidates. Such studies must be completed within 12 months of the start date of the award. If the studies are not completed within 12 months of award initiation, the government reserves the right to terminate the award. - Toxicology screening - Pharmacokinetics (e.g., absorption, distribution, metabolism, and excretion) studies - Pharmacodynamic studies - Radiation dosimetry DOD FY10 Prostate Cancer Laboratory-Clinical Transition Award 4 - Development and validation of assays and reagents required to measure biological responses and molecular endpoints of the lead agent; such studies may only be proposed in conjunction with lead agent development - Combination of the lead agent with agents already in clinical testing or practice Studies proposed under this award should not include: - Target discovery - Drug screening - Development of devices - New combinations, formulations, or modifications of agents already in clinical testing or practice (other than in combination with the lead agent) - Mechanism of action studies - Prevention agents Projects involving human subjects or specimens will be supported only if they are exempt under Title 32 of the Code of Federal Regulations Section 219.101(b) (4) (32 CFR 219.101(b) (4)) or qualify for expedited review under 32 CFR 219.110 or 21 CFR 56.1102. Clinical trials are not allowed. In general, a clinical trial is defined as a prospective study where an intervention (e.g., device, drug, behavioral, surgical procedure, or other) is tested on human subjects for a measurable outcome. Additional information on the protection of human subjects and exempt or expedited review status may be found at https://www.bids.tswg.gov/TSWG/bids.nsf/5DD5E2BA50F02C18852572B1005F5B8B/$file/Title_32_CFR_Part_219.pdf). Applications proposing studies that do not qualify for exempt or expedited review status will be administratively withdrawn. The preclinical drug development process may require resources beyond those available at a single laboratory or organization. As such, the PI must disclose any patents issued or pending, and/or licenses granted and/or pending, with respect to the lead agent(s) as well as any known patents that may block the development of the lead agent(s). The PI must provide documentation, such as a Material Transfer Agreement, of access to and permission to use all intellectual and material property. Participating organizations must be willing to resolve potential intellectual and material property issues, and to remove organizational barriers that might interfere with the cooperation necessary to ensure that the proposed studies can be completed. PIs are expected to abide by the FDA existing and proposed guidances governing the conduct of preliminary studies and the collection of data in support of an IND application (refer to http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm). Applications must describe statistical analyses to support the proposed studies. Statistical analyses must be consistent with current FDA guidance.